Generic Yasmin Availability

Yasmin is a brand name of drospirenone/ethinyl estradiol, approved by the FDA in the following formulation(s):

YASMIN (drospirenone; ethinyl estradiol - tablet;oral-28)

Has a generic version of Yasmin been approved?

A generic version of Yasmin has been approved by the FDA. However, this does not mean that the product will necessarily be commercially available - possibly because of drug patents and/or drug exclusivity. The following products are equivalent to Yasmin and have been approved by the FDA:

DROSPIRENONE AND ETHINYL ESTRADIOL (drospirenone; ethinyl estradiol tablet;oral-28)

  • Manufacturer: BARR
    Approval date: May 9, 2008
    Strength(s): 3MG;0.03MG [AB]
  • Manufacturer: LUPIN LTD
    Approval date: December 18, 2012
    Strength(s): 3MG;0.03MG [AB]
  • Manufacturer: WATSON LABS
    Approval date: September 7, 2010
    Strength(s): 3MG;0.03MG [AB]

SYEDA (drospirenone; ethinyl estradiol tablet;oral-28)

  • Manufacturer: SANDOZ
    Approval date: March 28, 2011
    Strength(s): 3MG;0.03MG [AB]

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Yasmin. These medications may be counterfeit and potentially unsafe. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Ask your health care provider for advice if you are unsure about the online purchase of any medication.

See also: About generic drugs.

Related Patents

Patents are granted by the U.S. Patent and Trademark Office at any time during a drug's development and may include a wide range of claims.

  • Dihydrospirorenone as an antiandrogen
    Patent 5,569,652
    Issued: October 29, 1996
    Inventor(s): Beier; Sybille & Elger; Walter & Nishino; Yukishige & Wiechert; Rudolf
    Assignee(s): Schering Aktiengesellschaft
    Dihydrospirorenone, ##STR1## preferably together with an estrogen, can be used for the production of a pharmaceutical agent suitable for treatment of hormonal irregularities during premenopause (menstruation stabilization), for hormonal substitution therapy during menopause, for treatment of androgen-induced disorders and/or for contraception.
    Patent expiration dates:
    • October 29, 2013
      ✓ 
      Patent use: PREVENTION OF PREGNANCY
  • Pharmaceutical composition for use as a contraceptive
    Patent 6,787,531
    Issued: September 7, 2004
    Inventor(s): Juergen; Hilman & Wolfgang; Heil & Ralph; Lipp & Renate; Heithecker & Michael; Huempel & Johannes W.; Tack
    Assignee(s): Schering AG
    A pharmaceutical composition comprises, as a first active agent, 6&bgr;,7&bgr;;15&bgr;,16&bgr;-dimethylene-3-oxo-17&agr;-pregn-4-ene-21,17-carbolactone (drospirenone) in an amount corresponding to a daily dosage, on administration of the composition, of from about 2 mg to about 4 mg, and, as a second active agent, 17&agr;-ethinylestradiol (ethinylestradiol) in an amount corresponding to a daily dosage of from about 0.01 mg to about 0.05 mg, together with one or more pharmaceutically acceptable carriers or excipients. In a specific embodiment, the composition consists of a number of separately packaged and individually removable daily dosage units placed in a packaging unit and intended for oral administration for a period of at least 21 consecutive days, wherein said daily dosage units comprises the combination of drospirenone and ethinylestradiol. The composition may further comprise 7 or less daily dosage units containing no active agent or containing ethinylestradiol alone.
    Patent expiration dates:
    • August 31, 2020
      ✓ 
      Drug product
  • PROCESSING FOR PRODUCING OF DROSPIRENONE (6β, 7β, 15β, 16β-DIMETHYLENE-3-OXO-17α-PREGN-4-EN-21, 17-CARBOLACTONE, DRSP) AS WELL AS 7α-(3-HYDOXY-1-PROPLY)-6β, 7β; 15β, 16β-DIMETHYLENE-5β-ANDR
    Patent 6,933,395
    Issued: August 23, 2005
    Inventor(s): Mohr; Jörg-Thorsten & Nickisch; Klaus
    Assignee(s): Schering AG
    Process for the production of drospirenone (6β,7β; 15β,16β-dimethylene-3-oxo-17α-pregn-4-ene-21,17-carbolactone, DRSP) (1) and 7α-(3-hydroxy-1-propyl)-6β,7β; 15β,16β-dimethylene-5β-androstane-3β,5,17β-triol (ZK 92836) and 6β,7β; 15β,16β-dimethylene-5β-hydroxy-3-oxo-17α-androstane-21,17-carbolactone (ZK 90965) as intermediate products of the process.
    Patent expiration dates:
    • August 11, 2017
      ✓ 
      Drug substance

Glossary

TermDefinition
Drug PatentA drug patent is assigned by the U.S. Patent and Trademark Office and assigns exclusive legal right to the patent holder to protect the proprietary chemical formulation. The patent assigns exclusive legal right to the inventor or patent holder, and may include entities such as the drug brand name, trademark, product dosage form, ingredient formulation, or manufacturing process A patent usually expires 20 years from the date of filing, but can be variable based on many factors, including development of new formulations of the original chemical, and patent infringement litigation.
Drug ExclusivityExclusivity is the sole marketing rights granted by the FDA to a manufacturer upon the approval of a drug and may run simultaneously with a patent. Exclusivity periods can run from 180 days to seven years depending upon the circumstance of the exclusivity grant.
RLDA Reference Listed Drug (RLD) is an approved drug product to which new generic versions are compared to show that they are bioequivalent. A drug company seeking approval to market a generic equivalent must refer to the Reference Listed Drug in its Abbreviated New Drug Application (ANDA). By designating a single reference listed drug as the standard to which all generic versions must be shown to be bioequivalent, FDA hopes to avoid possible significant variations among generic drugs and their brand name counterpart.
ABProducts meeting necessary bioequivalence requirements. Multisource drug products listed under the same heading (i.e., identical active ingredients(s), dosage form, and route(s) of administration) and having the same strength (see Therapeutic Equivalence-Related Terms, Pharmaceutical Equivalents) generally will be coded AB if a study is submitted demonstrating bioequivalence. In certain instances, a number is added to the end of the AB code to make a three character code (i.e., AB1, AB2, AB3, etc.). Three-character codes are assigned only in situations when more than one reference listed drug of the same strength has been designated under the same heading. Two or more reference listed drugs are generally selected only when there are at least two potential reference drug products which are not bioequivalent to each other. If a study is submitted that demonstrates bioequivalence to a specific listed drug product, the generic product will be given the same three-character code as the reference listed drug it was compared against.
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